Clinical trial · Interventional
Pilot Study on Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) as Neoadjuvant Therapy for Platinum-refractory Muscle-invasive Bladder Cancer
A Single-Arm, Open-Label, Multicenter Pilot Study：Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) for Platinum-refractory Muscle-Invasive Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial aims to evaluate the efficacy, safety, and biological mechanisms of rutin combined with tislelizumab and GC(Gemcitabine and Cisplatin) in platinum-refractory muscle-invasive bladder cancer patients. Key research questions include: 1. Whether rutin regulates epigenetic mechanisms in tumor cells from platinum-refractory bladder cancer patients and modulates the tumor immune microenvironment. 2. Evaluating the safety and adverse events of the combination treatment in platinum-refractory bladder cancer patients. 3. Assessing the disease control rate in platinum-refractory bladder cancer patients receiving this therapy. Patients with MIBC who exhibit no response (stable disease or progressive disease) after two cycles of neoadjuvant GC chemotherapy will receive two cycles of rutin combined with tislelizumab and GC. Safety and adverse events will be assessed after each cycle of combinational treatment. Therapeutic response will be evaluated by contrast-enhanced MRI, and surgical decisions (transurethral resection, partial cystectomy, or radical cystectomy) will be made by two senior urologists. Epigenetic alterations and the changes in immune microenvironment will be analyzed post-treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, Cisplatin | Drug | — | UNRESOLVED |
| Rutin | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rutin combined with Tislelizumab and GC
- description
- Patients with MIBC who exhibit no response (stable disease or progressive disease) after two cycles of neoadjuvant GC chemotherapy (Cisplatin 100 mg/m² D2 q3w and Gemcitabine 1000 mg/m² D1, D8 q3w) will receive two cycles of rutin (40 mg tid.) combined with tislelizumab (200 mg D1 q3w) and GC (Cisplatin 100 mg/m² D2 q3w and Gemcitabine 1000 mg/m² D1, D8 q3w). Safety and adversed events will be assessed after every cycle of combinational treatment. Therapeutic response will be evaluated by contrast-enhanced MRI, and surgical decisions (transurethral resection, partial cystectomy, or radical cystectomy) will be made by two senior urologists. Epigenetic alterations and changes in the immune microenvironment will be analyzed post-treatment.
- interventionNames
- Drug: Rutin
- Drug: Gemcitabine, Cisplatin
- Drug: Tislelizumab
Primary outcomes (1)
- measure
- Tumor microenvironment
- timeFrame
- From enrollment to the end of treatment at 6 weeks
- description
- Immune microenvironment and epigenetic alterations in bladder tumors, including immune cell components.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with cT2-cT4N0M0 muscle-invasive bladder cancer (MIBC) * No response after 2 cycles of GC neoadjuvant chemotherapy * No prior use of systemic immunotherapy or target therapy * Tumor is measurable according to New response evaluation criteria in solid tumours: Revised RECIST guideline * ECOG (ZPS, 5-point scale) 0-1 Exclusion Criteria: * Age less than 18 years * Patients with severe cardiac, cerebral, hepatic, or renal disease * Severely malnourished patients * Patients with mental illness and those without insight and unable to express exactly * Combined with malignant tumors of other organs * Systemic infectious diseases
References
Publications (0)
Data not yet available